WO2008137644A1 - Coussinet pour interface avec patient - Google Patents

Coussinet pour interface avec patient Download PDF

Info

Publication number
WO2008137644A1
WO2008137644A1 PCT/US2008/062368 US2008062368W WO2008137644A1 WO 2008137644 A1 WO2008137644 A1 WO 2008137644A1 US 2008062368 W US2008062368 W US 2008062368W WO 2008137644 A1 WO2008137644 A1 WO 2008137644A1
Authority
WO
WIPO (PCT)
Prior art keywords
cushion
flap
degrees
frustum
angle
Prior art date
Application number
PCT/US2008/062368
Other languages
English (en)
Inventor
Gerald E. Mcginnis
Peter Chi Fai Ho
Eugene N. Scarberry
Lance Busch
Jr. Joseph M. Miceli
Original Assignee
Ric Investments, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ric Investments, Llc filed Critical Ric Investments, Llc
Priority to BRPI0810965-6A2A priority Critical patent/BRPI0810965A2/pt
Priority to EP08747462.3A priority patent/EP2144657B1/fr
Priority to CN200880014143.0A priority patent/CN101678187B/zh
Priority to JP2010506669A priority patent/JP5912250B2/ja
Priority to AU2008247617A priority patent/AU2008247617B2/en
Publication of WO2008137644A1 publication Critical patent/WO2008137644A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0616Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0633Means for improving the adaptation of the mask to the patient with forehead support
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0633Means for improving the adaptation of the mask to the patient with forehead support
    • A61M16/0638Means for improving the adaptation of the mask to the patient with forehead support in the form of a pivot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0633Means for improving the adaptation of the mask to the patient with forehead support
    • A61M16/0644Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
    • A61M16/0655Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a linear or curvilinear slide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0683Holding devices therefor

Definitions

  • the present invention pertains to a respiratory patient interface used to deliver gas to a user.
  • the present invention is related to a respiratory patient interface having a cushion with a flap having a frustum-shaped portion.
  • Obstructive sleep apnea or OSA, obstructive sleep hypopnea, and upper airway resistance syndrome are among a variety of known disorders characterized by episodes of complete or partial upper airway obstruction during a state of diminished consciousness, such as sleep, anesthetization, or post anesthesia.
  • OSA, hypopnea, and UARS cause intermittent interruption of ventilation during sleep with the consequence of potentially severe oxyhemoglobin desaturation.
  • those afflicted with OSA, hypopnea, and UARS experience repeated, frequent arousal from sleep in response to the oxygen deprivation. The arousals result in sleep fragmentation and poor sleep continuity.
  • Consequences of OSA, hypopnea, and UARS may include debilitating daytime sleepiness and cognitive dysfunction, systemic hypertension, cardiac dysrythmias, pulmonary arterial hypertension and congestive heart failure. Other consequences may include a predisposition to myocardial infarction, angina pectoris, stroke, right ventricular dysfunction with cor pulmonale, carbon dioxide retention during wakefulness as well as during sleep, and continuous, reduced arterial oxygen tension. Moreover, the cognitive impairment resulting from OSA, hypopnea, and UARS puts those afflicted at elevated risk of accidents.
  • OSA, hypopnea, and UARS can include both anatomic and functional abnormalities of the upper airway that result in increased airflow resistance. Such abnormalities may include narrowing of the upper airway due to suction forces created during inspiration, the effect of gravity pulling the tongue back to oppose the pharyngeal wall, and insufficient muscle tone in the upper airway dilator muscles, among others. It is also believed that excessive soft tissue in the anterior and lateral neck, as commonly observed in obese persons, can apply sufficient pressure to internal structures to narrow the upper airway and restrict airflow.
  • a typical positive airway pressure device comprises a gas source (e.g., a blower, gas storage container) that delivers gas via a delivery conduit to a patient interface, such as a mask.
  • a gas source e.g., a blower, gas storage container
  • CPAP continuous positive airway pressure
  • variable airway pressure such as a bi-level pressure that varies with the patient's respiratory cycle, or an auto-titrating pressure that varies with the monitored condition of the patient.
  • Pressure support therapies are also provided to treat other medical and respiratory disorders, such as Cheynes-Stokes respiration, congestive heart failure, and stroke.
  • This mask has an outer shell coupled to a cushion which includes a coupling portion, a middle portion, and a flap portion.
  • the coupling portion couples the cushion to the outer shell; the middle portion provides clearance between the flaps and the coupling portion; and the flap portion has flaps that are inwardly directed such that they face one another.
  • this mask includes a variety of features to vary the amount of support and/or sealing provided by the cushion to balance the competing goals of comfort and functionality locally. In some locations, more support may be required. In other areas more flexibility may be required. This application discloses several alternatives to achieve this goal.
  • the cushion may include one or more pleats, the wall thickness may be varied to adjust the amount of support, or flexibility may be adjusted portionally about the cushion.
  • this device still utilizes inwardly directed flaps which may not form an optimum seal on some users. Instead, the flaps may tend to crumple or buckle.
  • a cushion for a respiratory mask having a shell and a cushion.
  • the cushion includes three portions: a flap portion, a middle portion, and a coupling portion.
  • the coupling portion is configured to couple the cushion to the shell of the respiratory mask.
  • the middle portion extends between the flap portion and the coupling.
  • the flap portion of the present embodiment of the invention includes a shoulder portion and a frustum-shaped portion extending towards the face of the user. The frustum-shaped portion extends away from the middle portion and terminates at an opening such that the opening is non-coplanar relative to the middle portion.
  • an embodiment of the present invention discloses a respiratory mask having a shell and a cushion.
  • the cushion includes three portions: a flap portion, a middle portion, and a coupling portion.
  • the coupling portion is configured to couple the cushion to the shell of the respiratory mask.
  • the middle portion extends between the flap portion and the coupling.
  • the flap portion of the present embodiment of the invention includes a frustum- shaped portion extending from the flap portion towards the face of the user. The frustum-shaped portion extends away from the middle portion and terminates at an opening such that the opening is non-coplanar with the shoulder portion.
  • an embodiment of the present invention discloses a gas supply assembly for delivering a supply of breathing gas to a user.
  • the gas supply includes a gas supply source such as a compressor and/or gas supply container for generating a breathing gas for use by a user.
  • a conduit Connected to the gas supply is a conduit.
  • the conduit is in turn connected to a respiratory mask to provide fluid communication between the gas supply source and the respiratory mask.
  • the respiratory mask of the present invention has a shell and a cushion.
  • the cushion includes three portions: a flap portion, a middle portion, and a coupling portion.
  • the coupling portion is configured to couple the cushion to the shell of the respiratory mask.
  • the middle portion extends between the flap portion and the coupling portion and provides clearance between the flap portion and the coupling portion so that the user's face does not make contact with the coupling portion.
  • the flap portion of this embodiment includes a frustum-shaped portion extending from the shoulder portion towards the face of the user. The frustum-shaped portion terminates at an opening such that the opening is non- coplanar with the shoulder portion.
  • an embodiment of the present invention discloses a gas supply assembly for delivering a supply of breathing gas to a user.
  • the gas supply includes a gas supply source such as a compressor and/or gas supply container for generating a breathing gas for use by a user.
  • a conduit Connected to the gas supply is a conduit.
  • the conduit is in turn connected to a respiratory mask to provide fluid communication between the gas supply source and the respiratory mask.
  • the respiratory mask of the present invention has a shell and a cushion.
  • the cushion includes three portions: a flap portion, a middle portion, and a coupling portion. The coupling portion is configured to couple the cushion to the shell of the respiratory mask.
  • the middle portion extends between the flap portion and the coupling portion and provides clearance between the flap portion and the coupling portion so that the user's face does not make contact with the coupling portion.
  • the flap portion of this embodiment includes a frustum-shaped portion extending from the shoulder portion towards the face of the user. The frustum-shaped portion terminates at an opening such that the opening.
  • the frustum-shaped portion includes an apex region, corner regions, side regions, and a base region. The frustum-shaped portion extends away from the coupling portion extends with multiple different angles about the flap.
  • an embodiment of the present invention discloses a gas supply assembly for delivering a supply of breathing gas to a user.
  • the gas supply includes a gas supply source such as a compressor and/or gas supply container for generating a breathing gas for use by a user.
  • a conduit Connected to the gas supply is a conduit.
  • the conduit is in turn connected to a respiratory mask to provide fluid communication between the gas supply source and the respiratory mask.
  • the respiratory mask of the present invention has a shell and a cushion.
  • the cushion includes three portions: a flap portion, a middle portion, and a coupling portion.
  • the coupling portion is configured to couple the cushion to the shell of the respiratory mask.
  • the middle portion extends between the flap portion and the coupling portion and provides clearance between the flap portion and the coupling portion so that the user's face does not make contact with the coupling portion.
  • the flap portion of this embodiment includes a frustum-shaped portion extending from the shoulder portion towards the face of the user. The frustum-shaped portion terminates at an opening such that the opening.
  • the frustum-shaped portion includes an apex region, corner regions, side regions, and a base region.
  • the frustum-shaped portion extends away from the coupling portion extends with multiple different angles about the flap. The largest angle occurs at about 15 degrees to approximately 60 degrees on either side of the apex region.
  • an embodiment of the present invention discloses a cushion for a respiratory mask having a shell and a cushion.
  • the cushion includes three portions: a flap portion, a middle portion, and a coupling portion.
  • the coupling portion is configured to couple the cushion to the shell of the respiratory mask.
  • the middle portion extends between the flap portion and the coupling portion.
  • the flap portion is configured to form a seal with the face of the user and extends outwardly and inwardly away from the middle portion and terminates at an opening.
  • FIG. 1 is an exploded perspective view of the mask of a first embodiment of a mask according to the principles of the present invention
  • FIG. 2 is an exploded side elevational view of the mask of FIG. l;
  • FIG. 3 is a perspective view of a mask retainer ring for the mask of FIG. 1 ;
  • FIG. 4A, 4B, 4C, and 4D are perspective, side, front, and rear elevational views of the cushion of FIG. 1 ;
  • FIG. 5 is a cross-sectional view of the cushion taken along line
  • FIG. 6 is a top plan view of the cushion used in the mask of FIG. l;
  • FIG. 7 is a top plan view of a second embodiment of the cushion
  • FIG. 8 is a side perspective view of a third embodiment of the cushion
  • FIG. 9 is a rear elevational view of the cushion of FIG. 8;
  • FIG. 10 is a front elevational view of the cushion of FIG. 8;
  • FIG. 11 is a side elevational view of the cushion of FIG. 8;
  • FIG. 12 is a top plan view of the cushion of FIG. 8;
  • FIG. 13 is a chart depicting the flap angle for the frustum-shaped portion of the cushion of FIG. 8;
  • FIG. 14 is a perspective view of a fourth embodiment of the cushion
  • FIG. 15 is a bottom plan view of the cushion of FIG. 14;
  • FIG. 16 is a top plan view of the cushion of FIG. 14;
  • FIG. 17 is a front elevational view of the cushion of FIG. 14;
  • FIG. 18 is a rear elevational view of the cushion of FIG. 14;
  • FIG. 19 is a side elevational view of the cushion of FIG. 14;
  • FIG. 20 is a perspective view of a fifth embodiment of the cushion
  • FIG. 21 is a top plan view of the cushion of FIG. 20;
  • FIG. 22 is a side elevational view of the cushion of FIG. 20;
  • FIG. 23 is a front elevational view of the cushion of FIG. 20;
  • FIG. 24 is a rear elevational view of the cushion of FIG. 20;
  • FIG. 25 is a perspective view of a sixth embodiment of the cushion.
  • FIG. 26 is an elevational view of the cushion of FIG. 25;
  • FIG. 27 is a side elevational view of a seventh embodiment of the cushion located on the face of a patient;
  • FIG. 28A and 28B are a top plan view and a cross-sectional view of the cushion of FIG. 27; and
  • FIG. 29 is a top plan view of an eight embodiment of the cushion.
  • FIGS. 1 - 3 schematically illustrates an exemplary embodiment of respiratory mask 30 according to the principles of the present invention.
  • Mask 30 includes a cushion 32 attached to a shell 34 by a mask retention ring 36.
  • Cushion 30 is configured to seal with the face of the patient.
  • the retention ring fits about cushion 32 and captures a portion of the cushion between retention ring 36 and shell 34 to securely hold the cushion and the shell together.
  • the mask also includes an insert 38 sandwiched between the cushion and the shell.
  • the shell is connected to a gas source 40 by a conduit 42.
  • the gas source may be any of the compressor-type positive pressure devices known in the art including but not limited to continuous positive airway pressure, bi-level positive airway pressure, or any other similar positive pressure device.
  • the gas source may generate a positive, negative or ambient pressure environment.
  • the gas source may include alone or in combination with a compressor-type device a gas storage container providing oxygen alone or in combination with other breathing gases as deemed appropriate for use in a particular application.
  • the conduit may be any suitable conduit known in the art capable of providing fluid communication between a gas source and a mask.
  • the conduit may be planar-cylindrical or corrugated tubing.
  • the tube may be of any suitable length and diameter appropriate for the delivery of gas to a user.
  • One end 44a of the conduit is configured to connect to the conduit coupling while the other end 44b is configured to be coupled to the gas source.
  • the shell in one embodiment, has a generally triangular-shaped body 46 with a conduit coupling 48 connected to conduit 42.
  • the conduit coupling is rotatable so that the tube may be oriented in any suitable direction to prevent becoming tangled or occluded while maintaining a seal with the shell.
  • the conduit coupling may be formed to direct the conduit in any desirable angle relative to the mask. As shown, the conduit coupling is bent to form an elbow so that the tube extends approximately parallel relative to the body of the shell.
  • Extending from the shell is an extension, or frame, 50.
  • the extension terminates at a forehead support 52 having a pad 54.
  • the extension may be fixed or it may be telescopically adjustable relative to the mask so that the distance between the mask and the forehead support may be adjusted to accommodate users of different ages or facial characteristics.
  • the forehead support may be fixed to the extension or mounted to the extension by a pivot connection.
  • the pad is configured to contact the user's forehead to provide support and comfort to the user, and may be solid, or include a liquid or gel to enhance comfort.
  • the device also includes ears 56 extending from the forehead support and latches 58 extending from the shell.
  • Ears 56 in combination with latches 58 are used to secure the mask on the face of the user via a headgear assembly, not shown.
  • the ears and latches may have a variety of configurations including but not limited to those shown in U.S. Patent Publication No. 2006- 0225740. The contents of which are hereby incorporated by reference.
  • Ledges 60 extend outwardly about the shell are configured to interface with retention ring 36 to connect the retention ring to the shell.
  • the connection ring 36 has a generally triangular-shaped body 61 with an L-shaped cross-section defined by a top portion 62 and a skirt 64.
  • the body 61 further includes ledges 66.
  • the ledges are configured to captured ledges 60 to hold the retention ring in place relative to the shell.
  • the retention ring also includes openings 68 to enhance flexibility and decrease unnecessary material utilization in the retention ring.
  • the retention ring also includes groove 70 which further enhances flexibility and provides a convenient location to insert an object to pry the retention ring free from the shell to disassemble the mask.
  • Cushion 32 may be connected to the shell 34 in a variety of other methods known in the art. For instance, the cushion could be attached via an adhesive. Alternatively, the cushion could be attached by overmolding the cushion onto the shell. Or, the cushion could be constructed from a single unitary structure without a separate shell.
  • the mask may include an insert 38 located between the shell and the retention ring.
  • the insert enhances support and comfort to the user, and can be formed from a solid material or filled with a liquid, gel, any other suitable material, or combination thereof.
  • the insert as shown, roughly conforms to the internal contours of the cushion; however, the insert could have a variety of other configurations and could be located in a variety of other locations to enhance the support and/or the comfort of a particular portion of the mask as desired.
  • cushion 32 has a unique configuration. Specifically, cushion 32 has a generally triangular-shaped body 72 configured to contact the face of the user and provide a fluid-tight seal so that the gas supplied by the gas source may be efficiently communicated to the user. Generally, the body has an apex region 74 and corner regions 76. Extending between apex region 74 and corner regions 76 are side regions 78, and extending between corner regions 76 is a base region 80. The body also has a coupling portion 82 configured to couple the cushion to the shell and a flap portion 86 configured to contact the face of the user.
  • the coupling portion includes a coupling apex portion 90, coupling corner portions 92, coupling side portions 94, and coupling base portion 96.
  • the middle portion includes a middle apex portion 98, middle corner portions 100, middle side portions 102 and a middle base portion 104.
  • the flap portion includes a flap apex portion 106, flap corner portions 108, flap side portions 110, and a flap base portion 112.
  • the coupling portion of the cushion has a collar 114 which is captured by the top portion 62 of the retention ring 36 to form a seal between the retention ring and the cushion. Adjacent the collar is a lip 116 radially spaced inwardly by an undercut 1 18 which seals with the insert.
  • the insert in turn, seals against the shell.
  • the insert may be omitted. If omitted, the lip may be configured to seal directly against the body of the shell.
  • the middle side portion of the cushion has a generally dome-shaped configuration extending between the coupling side portion and the flap side portion.
  • the sides 78 have an apex-proximal portion 120, a central portion 122, and a base-proximal portion 124.
  • the height the sides 78 extend away from the coupling portion 82 is greater in the central portion 122 than in the apex-proximal portion 120 or the base-proximal portion 124.
  • Flap portion 86 has a shoulder 126.
  • shoulder 126 is configured to roughly conform to the facial features of a user about the nasal portion to enhance the seal with the face of the user.
  • the shoulder forms an annular ring about the cushion and traces a nonlinear path that roughly conforms to the complex geometry of the user's face.
  • the shoulder defines an apex-proximal flap surface 128, a central flap surface 130, and a base proximal flap surface 132.
  • Angle 136 of the central flap surface is acute.
  • Angle 134 of the apex-proximal flap surface and angle 138 of the base-proximal flap surface 132 are also acute; however angle 134 and angle 138 are greater than angle 136.
  • the shoulder defines an apex flap surface 140 and a base flap surface 142.
  • the apex flap surface comes to a rounded point in the apex region while the base flap surface has a low flat U- shaped configuration in the base portion.
  • the flap portion includes a frustum-shaped portion 144 extending from shoulder 126 and terminating at opening 168.
  • the frustum-shaped portion extends outwardly from the cushion and inwardly.
  • the opening is located at least 1/8 inch above the shoulder or middle portion and at least 1/2 inch inboard of the shoulder or middle portion.
  • the frustum- shaped portion extends away from the shoulder and has a frustum-like shape.
  • the frustum-shaped portion may have a variety of geometric shapes.
  • the frustum-shaped portion has a frusta- pyramidal shape defined by a frusta-apex 146, frusta-corners 148, frusta-sides 150 and a frusta-base 152.
  • the frusta-apex 146 extends at an angle 158; frusta-base 152 extends at an angle 162; frusta-sides 150 extend upward at an angle 164; frusta-corners 148 extend at an angle 160.
  • These angles are shown measured from the midpoint of each respective region. Of course, the angles smoothly transition from each angle to the next angle in the corresponding adjacent region.
  • FIG. 5 shows a cross-sectional view of the cushion.
  • sides 78 are substantially planar along the majority of the sides.
  • the sides could have a wall thickness that varies to adjust the flexibility and rigidity of the cushion.
  • the cushion could also include pleats to further adjust the flexibility and rigidity of the cushion as best appreciated with reference to pending U.S. Patent Application Publication No. 2006-0130844. The contents of which are hereby incorporated by reference.
  • Opening 168 may have a variety of configurations. Two different opening geometries are shown in FIG. 6 and FIG. 7. For instance, the opening may have a teardrop or triangular-shaped cutout as shown in FIG. 6.
  • the opening may have a star-shaped cutout as shown in FIG. 7.
  • the star-shaped cutout provides protruding flaps 166.
  • the opening may have a variety of other shapes without departing from the scope of the present invention including but not limited to a circular, ovular, triangular, rectangular, or any other polygonal shape with or without protruding flaps.
  • FIGS. 8-12 This embodiment is similar to the previous embodiment except that it has a more subtle transition from the shoulder to the frustum-shaped portion, and the angles of the frustum-portions are more acute than in the previous embodiment.
  • the present invention provides a cushion 200 having a generally triangular-shaped body 202 configured to contact the face of the user and provide a fluid-tight seal so that the gas supplied by the gas source may be communicated to the user.
  • the body has an apex region 204 and corner regions 206. Extending between the apex region 204 and corner regions 206 are side regions 208. Extending between corner regions 206 is base region 210.
  • the body also has a coupling portion 212 configured to couple the cushion to the shell and a flap portion 216 configured to contact the face of the user. Between the flap portion 216 and the coupling portion 212 is a middle portion 214 configured to provide clearance between the flap portion and the coupling portion.
  • the coupling portion includes a coupling apex portion 218, coupling corner portions 220, coupling side portions 222, and coupling base portion 224.
  • the middle portion includes a middle apex portion 226, middle corners 228, middle sides 230 and a middle base 232.
  • the flap portion includes a flap apex portion 234, flap corner portions 236, flap side portions 238, and a flap base portion 240.
  • the coupling portion of the cushion has a collar 242 which is captured by the top portion 62 of the retention ring 36 to form a seal between the retention ring and the cushion (shown in FIG. 1). Adjacent the collar is a lip 244 radially spaced inwardly by an undercut 246 which seals with the insert.
  • the insert in turn, seals against the shell.
  • the insert may be omitted. If omitted, the Hp may be configured to seal directly against the body of the shell.
  • the middle side portion of the cushion has a generally dome-shaped configuration extending between the coupling side portion and the flap side portion.
  • the sides 230 have an apex- proximal portion 248, a central portion 250, and a base-proximal portion 252.
  • the height middle sides 230 extend away from coupling portion 212 is greater in the central portion 250 than in the apex-proximal portion 248 or the base- proximal portion 252.
  • the flap portion 216 has a shoulder
  • the shoulder which is configured to roughly conform to the facial features of a user about the nasal portion to enhance the seal with the face of the user.
  • the shoulder forms an annular ring about the cushion and traces a nonlinear path that roughly conforms to the complex geometry of the user's face.
  • the shoulder defines an apex-proximal flap surface 256, a central flap surface 258, and a base proximal flap surface 260.
  • Angle 264 of the central flap surface is acute.
  • Angle 262 of the apex-proximal flap surface and angle 266 of the base- proximal flap surface 260 are also acute; however angle 262 and angle 266 are greater than angle 264.
  • the shoulder As shoulder passes around and in to apex region 204 and base portion 210, the shoulder defines an apex flap surface 256 and a base flap surface 258.
  • the apex flap surface comes to a rounded point in the apex region while the base flap surface has a low flat U-shaped configuration in the base portion.
  • the flap portion of the present invention also includes a frustum- shaped portion 270 extending from shoulder 254 and terminating at opening 280 whereas prior art cushions have flap portions that terminate at the shoulder which extends approximately normal to the face of the user a short distance from the periphery of the cushion.
  • the frustum-shaped portion extends from the shoulder and has a frustum-like shape.
  • the frustum-shaped portion may have a variety of geometric shapes. For instance, in the present embodiment, the frustum-shaped portion has a frusta-pyramidal shape defined by a frusta-apex 272, frusta-corners 274, frusta-sides 276 and a frusta-base 278.
  • the frusta- apex 272 extends at an angle 282; frusta-base 278 extends at an angle 284; frusta- sides 276 extend upward at an angle 286; and frusta-corners 274 extend at an angle 288. These angles are shown measured from the midpoint of each respective region. Of course, the angles smoothly transition from each angle to the next angle in the corresponding adjacent region.
  • the angle of frustum-shaped portion 144, 270 varies about the respective cushion 32, 200.
  • the angles vary continuously about the cushion as angle ⁇ , shown on FIGS. 6 and 12, sweeps about the mask from 0 degrees at apex regions 74, 204 to 180 degrees at the middle of base 80, 210.
  • FIG. 13 depicts the angle for cushion 32, cushion 200, and another embodiment not shown elsewhere.
  • these embodiments have angles which trend in approximately the same manner but vary by degree.
  • the angles for cushion 32 are more sever than the angles for the undepicted embodiment or cushion 200.
  • Table 1 While the precise angle of the frustum-portion is described in the Table I 5 and FIG. 13, various other embodiments could be constructed utilizing the unique aspects of the present invention without using the precise angles described.
  • FIGS. 14-19 This embodiment is similar to the previous embodiments. Yet, unlike the previous embodiments, the present embodiment is a low profile cushion configured to fit closely about the tip of the nose.
  • this embodiment of the invention provides a cushion 300 which has a generally triangular-shaped body 302 configured to contact the face of the user and provide a fluid-tight seal so that the gas supplied by the gas source may be communicated to the user.
  • the body has an apex region 304 and corner regions 306. Extending between the apex region 304 and corner regions 306 are side regions 308, and extending between corner regions 306 is base region 310.
  • the body also has a coupling portion 312 configured to couple the cushion to the shell and a flap portion 316 configured to contact the face of the user. Between the flap portion 316 and the coupling portion 312 is a middle portion 314 configured to provide clearance between the flap portion and the coupling portion.
  • the coupling portion is substantially cylindrical in this embodiment. However, the coupling portion 312 may have a variety of other shapes.
  • the coupling portion may include an alignment feature, not shown, to align the cushion with the shell. For instance, the cushion and shell may have tabs and corresponding recesses to align the cushion.
  • the cushion is described as being attached to a shell. However, the cushion may be attached directly to conduit 42 or conduit coupling 48.
  • the middle portion includes a middle apex portion 326, middle corners 328, middle sides 330 and a middle base 332.
  • the flap portion includes a flap apex portion 334, flap corner portions 336, flap side portions 338, and a flap base portion 340.
  • Flap portion 316 has a shoulder 354 which is configured to roughly conform to the facial features of a user about the nasal portion to enhance the seal with the face of the user.
  • the shoulder forms an annular ring about the cushion and traces a nonlinear path that roughly conforms to the complex geometry of the user's face.
  • the shoulder When viewed from the side, the shoulder defines an apex-proximal flap surface 356, a central flap surface 358, and a base proximal flap surface 360.
  • Angle 364 of the central flap surface 356 is acute and preferably approximately zero.
  • Angle 362 of the apex-proximal flap surface and angle 366 of the base-proximal flap surface 360 are also acute; however angle 366 and angle 362 are greater than angle 364.
  • the shoulder passes around and in to the apex region 304 and base portion 310, the shoulder defines an apex flap surface 367 and a base flap surface 368.
  • the apex flap surface comes to a rounded point in the apex region while the base flap surface has a low flat U-shaped configuration in the base portion,
  • the flap portion of the present invention also includes a frustum- shaped portion 370 extending from shoulder 354 and terminating at opening 380 whereas prior art cushions have flap portions that terminate at the shoulder which extends approximately normal to the face of the user a short distance from the periphery of the cushion.
  • the frustum-shaped portion extends from the shoulder and has a frustum-like shape.
  • the frustum-shaped portion may have a variety of geometric shapes. For instance, in the present embodiment, the frustum-shaped portion has a frusta-pyramidal shape defined by a frusta-apex 372, frusta-corners 374, frusta-sides 376 and a frusta-base 378.
  • frusta-apex 372 extends at an angle 382; frusta-base 378 extends at an angle 384; frusta-sides 376 extend upward at an angle 386; and frusta-corners 374 extend upward at an angle 390. These angles are shown measured from the midpoint of each respective region. Of course, the angles smoothly transition from each angle to the next angle in the corresponding adjacent region.
  • this embodiment utilizes a frustum-shaped portion that utilizes different, and comparatively larger angled portions which are deemed advantageous in a low profile device. Of course, the angles could be different than those shown.
  • This embodiment utilizes a cushion that is configured to minimize the interface between the cushion and the face of the user both with respect to the surface area of the face enclosed and with respect to the amount of flap that contacts the user's face. To enhance these cushions, it has been found to be desirable to utilize a frustum-shaped portion that extends towards the face of the user with a larger angle to enhance preloading of the cushion as the nose of the user is inserted.
  • FIGS. 20-24 The present embodiment is similar to the previous embodiment. Yet, unlike previous embodiments, the present embodiment is a cushion configured to fit over the mouth and nose of the user rather than merely the nose.
  • the present invention provides a cushion 400 which has a generally triangular-shaped body 402 configured to contact the face of the user and provide a fluid-tight seal so that the gas supplied by the gas source may be communicated to the user.
  • the body has an apex region 404 and corner regions 406. Extending between the apex region 404 and corner regions 406 are side regions 408 and extending between corner regions 406 is base region 410.
  • the body also has a coupling portion 412 configured to couple the cushion to the shell and a flap portion 416 configured to contact the face of the user. Between the flap portion 416 and the coupling portion 412 is a middle portion 414 configured to provide clearance between the flap portion and the coupling portion.
  • the coupling portion includes a coupling apex portion 418, coupling corner portions 420, coupling side portions 422, and coupling base portion 424.
  • the middle portion includes a middle apex portion 426, middle corners 428, middle sides 430 and a middle base 432.
  • the flap portion includes a flap apex portion 434, flap corner portions 436, flap side portions 438, and a flap base portion 440.
  • the coupling portion of the cushion has a collar 442 having a plurality of serrations. Adjacent the collar is a lip 444 radially spaced inwardly by an undercut 446 which seals with the insert.
  • the insert seals against the shell.
  • the insert may be omitted. If omitted, the lip may be configured to seal directly against the body of the shell.
  • the middle side portion of the cushion has a generally dome-shaped configuration extending between the coupling side portion and the flap side portion.
  • the sides 430 have an apex-proximal portion 448, a central portion 450, and a base-proximal portion 452.
  • the height middle sides 430 extend away from coupling portion 412 is greater in the central portion 450 than in the apex- proximal portion 448 or the base-proximal portion 452.
  • the flap portion 416 in this embodiment, has a single continuous frustum-shaped flap portion 470 extending from the middle portion 414 and terminating at opening 480.
  • the frustum-shaped portion may have a variety of geometric shapes. For instance, in the present embodiment, the frustum-shaped portion has a frusta-pyramidal shape defined by a frusta-apex 472, frusta-corners 474, frusta-sides 476 and a frusta-base 478. As seen in FIGS.
  • frusta-apex 472 extends at an angle 482; frusta-base 478 extends at an angle 484; frusta-sides 476 extend upward at an angle 486; frusta-corners 474 extend at an angle 488. These angles are shown measured from the midpoint of each respective region. Of course, the angles smoothly transition from each angle to the next angle in the corresponding adjacent region.
  • FIGS. 25 and 26 Another alternative embodiment of the present invention is depicted in FIGS. 25 and 26.
  • Cushion 500 shown in this embodiment has a generally frusta-conical shape rather than the frusta-pyramidal shape of the previous embodiment.
  • This embodiment provides a more simplistic geometric shape which may result in manufacturing efficiencies.
  • the present embodiment includes a coupling portion 502, a middle portion 504, and a flap portion 506 terminating at an opening 508.
  • the coupling portion includes a collar 510.
  • the middle portion 504 and flap portion 506 smoothly transition into one another. Nonetheless, the flap portion of this embodiment still contacts the face of the user while the middle portion still spaces the flap portion from the coupling portion.
  • the cushion 500 extends upward and slightly inwardly at an acute angle 512. Angle 512 is approximately 75 degrees. Of course, a variety of other angles may be utilized.
  • FIGS. 27-28B Another alternative embodiment of the present invention is shown in FIGS. 27-28B.
  • This embodiment depicts a cushion 600 having a generally frusta-conical shape.
  • the cushion includes a coupling portion 602, a middle portion 604, and a flap portion 606.
  • the entire cushion 600 has a frusta- conical shape 632 terminating at an opening 608.
  • the coupling portion includes a collar 610 and a lip 612.
  • the cushion is configured to be coupled to a shell 614 by a retention ring 616.
  • Retention ring 616 includes a top surface 618 and a skirt 620.
  • the skirt includes a ledge 622 which engages surface 624. Sandwiched between the retention ring and the shell is the cushion.
  • the shell includes a groove 626 configured to receive Hp 612.
  • the present embodiment has a wall thickness that varies and curves inwardly becoming more acute.
  • the middle portion has a wall thickness that is thicker than the wall thickness of the flap portion.
  • the wall thickness of middle portion 604 is approximately 0.020 to 0.035 inches
  • wall thickness of flap portion 602 is approximately 0.005 to 0.010 inches.
  • the angle the middle portion and flap portion extend varies.
  • the middle portion extends at an angle 628 approximately normal to the coupling portion while the flap portion extends at an angle 630.
  • angle 628 of the middle portion is approximately 85 degrees and angle 630 of the flap portion is approximately 60 degrees.
  • FIGS. 29 Another alternative embodiment is shown in FIGS. 29.
  • the cushion 700 has a coupling portion 702, a middle portion 704, and a flap portion 706.
  • the flap portion includes an apex region 708, corner regions 710. Between the apex region 708 and the corner regions 710 are side regions 712. Between corner portions 710 is base portion 714.
  • the flap extends from middle portion 704 to opening 714.
  • the flaps include apertures 716.
  • a single aperture 716 may be used or multiple apertures 716 may be used about the flap portion 704.
  • the apertures may have a variety of shapes without departing from the scope of the present invention. The apertures may be placed closer towards the middle portion 704 or closer to opening 714.
  • the cushions of the present invention may be constructed from a variety of materials such as but not limited to Silicon.
  • the material may have a durometer of between 10 - 80 Shore A.
  • the material may have a durometer of approximately 40 Shore A.
  • the wall thickness may be varied.
  • the wall thickness may be between approximately 0.001 inch to 0.05 inch.
  • the wall thickness may be varied to create regions of comparative rigidity or flexibility, as shown in FIG. 28B.
  • the cushion may be shaped to have anatomical features as shown in FIGS. 1- 24, and 29; or, the cushion may be formed without anatomical features as shown in FIGS. 25-28. Common to both embodiments is the frustum-shaped flap portion.
  • a cushion which is preset with particularly desirable anatomical features may more easily conform to the facial characteristics of the user.
  • a cushion which lacks anatomical features may not start with an appropriate anatomical shape; yet, such a cushion does not have preset features which may be incompatible with the facial characteristics of a particular user. Accordingly, such cushions may accommodate a larger number of users with differing facial characteristics.
  • any suitable material may be utilized within the scope of the present invention.
  • the cushion in the event that the cushion is formed with a particular shape, it would be desirable to utilize a material which is, at least partially, elastically deformable. Elastically deformable materials regain their pre-stressed configuration once an applied force has been removed.
  • the cushion may be formed from a material that is, at least partially, plastically deformable such that it has little or no shape memory. This may be a desirable characteristic in the event that the cushion is formed without anatomical characteristics. As the cushion deforms to correspond to the facial characteristics of the user, the cushion does not have to overcome incompatible preset features.
  • the user of an embodiment of the present invention will place the cushion on their face and compress the mask to make a seal.
  • the mask is secured on the face of the user by a headgear assembly.
  • the shell in turn is coupled to the gas source via the conduit coupling. Due to the unique frustum portion of the cushion, as a force is applied to the flap portion, the flap portion smoothly rolls inwardly to form a seal with the patient's face. This configuration minimizes ripples or creases that result in discomfort or potentially compromise the seal integrity with the face of the user.

Landscapes

  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

L'invention propose un masque respiratoire ayant un coussinet et une coque, le coussinet ayant une partie de tronc de cône qui s'étend vers le visage de l'utilisateur pour fournir à l'utilisateur une interface plus grande, plus stable et plus confortable qui est en mesure de mieux se conformer à la géométrie complexe du visage de l'utilisateur.
PCT/US2008/062368 2007-05-02 2008-05-02 Coussinet pour interface avec patient WO2008137644A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
BRPI0810965-6A2A BRPI0810965A2 (pt) 2007-05-02 2008-05-02 Almofada para uso em uma máscara respiratória tendo um casco, máscara respiratória para uso no fornecimento de um gás a um usuário e conjunto de suprimento de gás
EP08747462.3A EP2144657B1 (fr) 2007-05-02 2008-05-02 Coussinet pour interface avec patient
CN200880014143.0A CN101678187B (zh) 2007-05-02 2008-05-02 用于患者接口的衬垫
JP2010506669A JP5912250B2 (ja) 2007-05-02 2008-05-02 患者インタフェース用のクッション
AU2008247617A AU2008247617B2 (en) 2007-05-02 2008-05-02 Cushion for a patient interface

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91549507P 2007-05-02 2007-05-02
US60/915,495 2007-05-02

Publications (1)

Publication Number Publication Date
WO2008137644A1 true WO2008137644A1 (fr) 2008-11-13

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ID=39943942

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/062368 WO2008137644A1 (fr) 2007-05-02 2008-05-02 Coussinet pour interface avec patient

Country Status (7)

Country Link
US (1) US8550080B2 (fr)
EP (1) EP2144657B1 (fr)
JP (1) JP5912250B2 (fr)
CN (1) CN101678187B (fr)
AU (1) AU2008247617B2 (fr)
BR (1) BRPI0810965A2 (fr)
WO (1) WO2008137644A1 (fr)

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US10071216B2 (en) 2008-05-29 2018-09-11 Naturs Design, Inc. Liner for use with respiratory mask
US11305082B2 (en) 2008-05-29 2022-04-19 Naturs Design, Inc. Liner for use with respiratory mask
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Also Published As

Publication number Publication date
EP2144657A1 (fr) 2010-01-20
BRPI0810965A2 (pt) 2015-01-27
JP5912250B2 (ja) 2016-04-27
EP2144657B1 (fr) 2020-03-04
EP2144657A4 (fr) 2017-10-25
US8550080B2 (en) 2013-10-08
JP2010525897A (ja) 2010-07-29
AU2008247617A1 (en) 2008-11-13
US20080302366A1 (en) 2008-12-11
CN101678187A (zh) 2010-03-24
CN101678187B (zh) 2014-07-16
AU2008247617B2 (en) 2013-05-30

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